General Information

Xtoro is specifically indicated for the treatment of acute otitis externa caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus.

Xtoro is supplied as a solution for topical administration. The recommended initial dose is as follows: Instill four drops in the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days.

Clinical Results

FDA Approval

The FDA approval of Xtoro was based on two randomized multicenter, vehicle controlled clinical trials. Xtoro dosed four drops twice daily for 7 days was superior to its vehicle for both clinical and microbiological outcomes, as well as in time to cessation of ear pain in patients with acute otitis externa. Among 560 patients (161 with an otowick) that were pathogen positive (baseline microbiological specimen that contained Staphylococcus aureus and/or Pseudomonas aeruginosa), clinical cure on Day 11 was 71% in Xtoro versus 37% in Vehicle. Among 1,234 patients who received study treatment (Intent to Treat population (ITT)), aged 6 months to 85 years, clinical cures were 71% for Xtoro and 50% in Vehicle.

Side Effects

Adverse effects associated with the use of Xtoro may include, but are not limited to, the following: